Active Ingredient
Zinc Oxide 13%
My Fair Baby
FDA Label NDC 47046-179
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Anicare Pharmaceuticals Pvt. Ltd. for the product My Fair Baby (NDC 47046-179). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protection
Use
- Helps treat and prevent diaper rash
- Soothes and relieves irritated skin
- Protects your baby's skin from wetness
Warnings
For external use only
When Using This Product
Avoid contact with the eyes
Stop Use And Ask A Doctor If
Condition worsens or does not improve within 7 days or symptoms clear up and occur again within a few days.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
Directions
- Change wet and soiled diapers promptly
- Cleanse the diaper area
- Allow to dry
- Ointment should be applied at every diaper change, specially at bedtime or anytime when exposure to wet diapers may be prolonged
Other Information
Store at 20° to 25°C (68° to 77°F)
Inactive Ingredients
Water, Mineral Oil, Petrolatum, Cetyl Alcohol, Ceteareth-25, Glyceryl Monostearate, Beeswax, Microcrystaline Wax, Fragrance, Dimethicone, Aloe Barbadensis Leaf Extract (Aloe Vera), Tocopheryl Acetate, Methylparaben, Propylparaben, Methylchloroisothiazolinone, Methylisothiazolinone, Carbomer
Carton Label
Package Label (Diaperrshcrmctn)
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